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Study: Pharmacokinetics, Safety Comparable Between CT-P13 Autoinjector and Pre-Filled Syringe
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Key Takeaways
- CT-P13 is the first infliximab biosimilar with both intravenous and subcutaneous formulations, approved for multiple indications in Europe.
- Phase 3 trials indicated higher clinical remission rates for the subcutaneous formulation compared to placebo in maintenance therapy.
The FDA previously accepted the biologic license application for CT-P13 as a subcutaneous formulation.
The pharmacokinetics and safety of CT-P13 (Zymfentra; Celltrion USA), a biosimilar to infliximab (Remicade; Janssen Immunology), were similar between autoinjector and pre-filled syringe administration, according to results of a study published in Clinical and Translational Science.1
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In January 2023, the FDA accepted the biologic license application for CT-P13 as a subcutaneous (SC) formulation, which became the first and only infliximab biosimilar to have both intravenous (IV) and SC formulations, according to an article. The drug has been approved in Europe for rheumatoid arthritis and the indication was expanded to include ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn disease (CD), and ulcerative colitis (UC) in 2020. The initial IV formulation was approved by the FDA in 2016. In 2 phase 3 trials from June 2024, investigators found that there were higher clinical remission rates for individuals treated with the SC formulation compared with the placebo at maintenance therapy following induction of the IV formulations.2-4
Both studies met the primary end point, with 62% of patients receiving CT-P13 and 32% receiving the placebo as treatment for CF achieving clinical remission. Further, 51% and 18% achieved endoscopic response, respectively. For UC, 43% and 21% of patients achieved clinical remission. Secondary end points, including clinical remission by abdominal pain, stool frequency, endoscopic-histologic mucosal improvement, and corticosteroid-free remission, were met.4
In the current study, investigators conducted the randomized, open-label, single-dose study at the Clinical Trial Center of Chungnam National University Hospital in Daejeon, Republic of Korea. Data was collected between February 16, 2021, and July 13, 2021, with treatment randomly assigned to patients as an auto injection (test drug) or pre-filled syringes (reference drug) in a 1:1 ratio. Each individual received a single dose of the subcutaneous formulation in the 120 mg dosage.1
A total of 147 individuals were included with 73 in the test drug group and 74 in the reference drug group. Investigators reported that 139 completed the study (70 in the test drug group and 69 in the reference drug group). Investigators collected blood samples before administration and 2016 hours after the start of the administration, according to the study authors. Between the 2 groups, investigators found that the geometric mean ratios of the AUCinf and C mac were 94.15% (test drug) and 92.48% (reference drug). Furthermore, both drugs achieved comparable pharmacokinetics, and immunogenicity was approximately 97.22% and 98.65%, respectively.1
For safety, 55.56% individuals in the study reported adverse events (AEs) in the test drug group and 55.41% in the reference drug group. The most frequently reported treatment-emergent AEs (TEAEs) for the test drug included increased C-reactive protein and increased blood creatine phosphokinase. For the reference drug, most common TEAEs included C-reactive protein followed by blood creatine phosphokinase and alanine aminotransferase.1
